Field of the Invention
At least one embodiment generally relates to a system for the integrated and automated analysis of DNA or protein, for example one comprising a single-use cartridge (card), an evaluation device and a device for signal recording and processing. In particular, at least one embodiment of the invention generally relates to a control device as part of the evaluation device for the fully automatic processing and evaluation of molecular diagnostic analyses with disposable cartridges (“lab-on-a-chip”) and also known as a biochip; see, commonly owned U.S. Patent Application Publication 2007/01411553). In addition, at least one embodiment of the invention also generally relates to a method for operating the type of system.
Description of Related Art
The significance of decentralized analysis devices (“point of care”, “near patient testing”) in molecular diagnostics or general medical technology is increasing. In addition, fast tests are becoming more and more important in the areas of foodstuff monitoring and environmental protection.
The general literature, but also especially the patent literature includes a large number of publications on the aforementioned topic: International Patent Application Publications WO 02/072 262 A1 and WO 02/073 153 A1 (which corresponds to U.S. Patent Application Publication 2005/0031490) disclose systems for application in biomedical technology in which samples taken in a decentralized manner are evaluated in a decentralized manner by means of an optionally mobile read-out device. The samples, in particular, are in this case collected in a single-use cartridge formed like a check card (“card”).
Such a cartridge for application in the DNA analysis of whole blood samples is disclosed in detail in International Patent Application Publication WO 2006/042 838 A1 and corresponding U.S. Pat. No. 7,851,227, not previously published. In this case, the following features of the cartridge are regarded as essential for automatically carrying out all the measures required for process analysis from individual partial processes in the cartridge:                the cartridge contains a system of microchannels and/or microcavities for a microfluidic process technology,        the microchannels or the microcavities have predetermined geometrical structures for receiving reagents, wherein        the reagents are stored in a storage-stable form at specific locations in the microchannels or the microcavities of the cartridge,        means are present for providing the dry-stored reagents for the respective partial process in a suitable form, in particular as a liquid reagent.Reference is expressly made to the disclosure of these features in the above earlier application.        
Furthermore, U.S. Patent Application Publications 2002/0179444 A1 and 2003/0148530 A1 disclose individual solutions for a blood diagnosis method and the associated signal processing. Specific problem solutions for the realization of the system of the type mentioned in the introduction comprising the previously described card and associated suitable means for evaluation are described in earlier applications in the name of the applicant that have not yet been published.